Sep 10, 2013 04:21 PM EDT By Russell Westerholm, UniversityHerald Reporter

The U.S. Food and Drug Administration has announced mandatory safety labeling changes for all analgesic opioids meant to treat pain classified as extended-release (ER) or long-acting (LA), according to an FDA News Release.

When made final, the class-wide safety labeling changes and new postmarket study requirements will help healthcare providers and primary care doctors individualize people's prescriptions based on the new language.

"The FDA is invoking its authority to require safety labeling changes and postmarket studies to combat the crisis of misuse, abuse, addiction, overdose, and death from these potent drugs that have harmed too many patients and devastated too many families and communities," said FDA Commissioner Margaret A. Hamburg, M.D. "Today's action demonstrates the FDA's resolve to reduce the serious risks of long-acting and extended release opioids while still seeking to preserve appropriate access for those patients who rely on these medications to manage their pain."

The new requirements are meant for ER/LA opioids that are used to treat pain severe enough to warrant constant use for an extended period of time. The revision to the safety labeling states the drugs should only be used if other treatments are inadequate, insufficient or not tolerated. The changes came because of the drugs' relation to addiction, abuse and misuse.

"The FDA's primary tool for informing prescribers about the approved uses of medications is the product labeling," said Douglas Throckmorton, M.D., deputy director for regulatory programs in the FDA's Center for Drug Evaluation and Research. "These labeling changes describe more clearly the risks and safety concerns associated with ER/LA opioids and will encourage better, more appropriate, prescribing, monitoring and patient counseling practices involving these drugs."

The new safety labeling will not be included with drugs used for as-needed pain relief.

Additionally, the FDA is requiring companies who manufacture these substances to conduct further research to gather more information as to the long-term effects ER/LA opioids.

"The FDA remains committed to improving the safety of opioids and to continuing to engage in efforts to evaluate and mitigate the risks associated with opioid use," said Dr. Throckmorton. "Today's safety labeling changes reflect the FDA's current understanding of the risks and benefits of these products. The FDA will evaluate the results of the postmarket studies, continue to monitor relevant safety data, and take further safety action, as warranted."

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